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NCT05797376CompletedPhase 4

Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inflammation

Source: ClinicalTrials.gov · Last updated 27 Dec 2024

Brief summary (registry, in English)

Primary Study Objective : To compare the effects of low-dose rivaroxaban plus aspirin versus aspirin on atherosclerotic plaque inflammation using serial FDG Positron Emission Tomography/Computed Tomography(PET-CT) imaging of carotid artery and ascending aorta. Secondary Study Objective : To compare the effects of low-dose rivaroxaban plus aspirin versus aspirin on biomarkers including high-sensitivity C-Reactive Protein(CRP) and lipid profiles.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
92 (actual)
First submitted
9 Mar 2023
Start date
Aug 2021
Primary completion date
Nov 2024
Lead sponsor
Asan Medical Center
NCT number
NCT05797376

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 92
  • From Aug 2021 to the primary completion date, Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated with carotid endarterectomy or stent placement
  • Need for dual antiplatelet therapy or oral anticoagulant therapy

Other illness

  • Stroke in 1 month or any hemorrhagic or lacuna stroke
  • Insulin requiring diabetes
  • Patients who have experienced critical organ bleeding within 1 year

Lab values

  • Severe left ventricular dysfunction (ejection fraction \< 30%)
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine aminotransferase(ALT) or aspartate aminotransferase(AST) \> 3 times upper limit of normal).

Other

  • Contraindications to rivaroxaban or aspirin.
  • Unwillingness or inability to comply with the procedures described in this protocol.
  • Patient's pregnant or breast-feeding or child-bearing potential.

Who the study is looking for

  • Men or women at least 18 years of age inclusive
  • Asymptomatic Carotid Artery Disease (diameter stenosis, 20-80%)
  • Inclusion criteria for the COMPASS trial (stable Peripheral Artery Disease(PAD); or stable Coronary Artery Disease(CAD) with 1 of age over 65 years, or age \<65 years plus atherosclerosis less than 2 vascular beds or less than 2 additional risk factors)
  • FDG Postron Emission Tomography(PET)/Computed tomogrphy(CT) shows hot uptakes at carotid artery (with or without hot uptake at ascending aorta)
  • The patient or guardian agrees to the study protocol and the schedule of clinical and FDG Postron Emission Tomography(PET)/Computed tomogrphy(CT) follow-up, and provides informed, written consent, as approved by the Institutional Review Board/Ethical Committee.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.